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A Randomized Trial of Induction Versus Expectant Management (ARRIVE)

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ClinicalTrials.gov Identifier: NCT01990612
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : January 25, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Study Description
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Brief Summary:
A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Condition or disease Intervention/treatment Phase
Labor and Delivery Procedure: Elective Induction of Labor Not Applicable

Detailed Description:
Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial
Study Start Date : March 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Expectant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
 Procedure: Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.


Outcome Measures
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Primary Outcome Measures :
  1. Composite of Severe Neonatal Morbidity and Perinatal Mortality [ Time Frame: delivery through 72 hours after birth ]

    Includes any one of:

    • Perinatal death
    • Need for respiratory support within 72 hours after birth
    • Apgar score of 3 or less at 5 minutes
    • Hypoxic-ischemic encephalopathy
    • Seizure
    • Infection (confirmed sepsis or pneumonia)
    • Meconium aspiration system
    • Birth trauma (bone fracture, neurologic injury or retinal hemorrhage)
    • Intracranial or subaleal hemorrhage
    • Hypotension requiring vasopressor support

  2. Perinatal Death (Component of Primary Outcome) [ Time Frame: antepartum pregnancy period through hospital discharge ]
    Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death

  3. Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome) [ Time Frame: Delivery through discharge ]
    Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation

  4. Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome) [ Time Frame: Delivery through 5 minutes after birth ]
    The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

  5. Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome) [ Time Frame: delivery through discharge ]
  6. Number of Infants With Neonatal Seizure (Component of Primary Outcome) [ Time Frame: Delivery through discharge ]
  7. Number of Infants With Neonatal Infection (Component of Primary Outcome) [ Time Frame: delivery through discharge ]
    Neonatal infection includes confirmed sepsis and/or confirmed pneumonia

  8. Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome) [ Time Frame: Delivery through discharge ]
  9. Number of Infants With Birth Trauma (Component of Primary Outcome) [ Time Frame: During the Delivery process ]
    Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis

  10. Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome) [ Time Frame: delivery through disharge ]
    Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma

  11. Hypotension Requiring Vasopressor Support (Component of Primary Outcome) [ Time Frame: delivery through discharge ]

Secondary Outcome Measures :
  1. Number of Participants With Cesarean Delivery [ Time Frame: delivery ]
  2. Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery [ Time Frame: delivery ]
    Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas

  3. Participants Who Had Operative Vaginal Delivery [ Time Frame: delivery ]
  4. Number of Participants Who Had Chorioamnionitis [ Time Frame: at any time from randomization through delivery ]
    Chorioamnionitis, defined as a clinical diagnosis before delivery

  5. Number of Participants With Third or Fourth Degree Perineal Laceration [ Time Frame: delivery ]
  6. Number of Maternal Deaths [ Time Frame: from randomization to hospital discharge ]
    Maternal death at anytime between randomization and hospital discharge.

  7. Number of Participants Admitted to Intensive Care Unit (ICU) [ Time Frame: delivery through hospital discharge ]
    Admission of the participant to the intensive care unit (ICU)

  8. Number of Participants Experiencing Hypertensive Disorder of Pregnancy [ Time Frame: Randomization to hospital discharge ]
  9. Number of Participants With Postpartum Hemorrhage [ Time Frame: delivery through hospital discharge ]

    defined as any of the following:

    • Transfusion
    • Non-elective hysterectomy
    • Use of two or more uterotonics other than oxytocin
    • Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade
    • Curettage

  10. Labor Agentry Scale Scores [ Time Frame: Between 6 hours after delivery and 8 weeks after delivery ]
    Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.

  11. Labor Pain Scores [ Time Frame: During labor and delivery ]
    Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.

  12. Number of Participants With Maternal Postpartum Infection [ Time Frame: delivery through discharge ]

    Defined as any of the following:

    • Clinical diagnosis of endometritis
    • Wound reopened for hematoma, seroma, infection or other reasons
    • Cellulitis requiring antibiotics
    • Pneumonia
    • Pyelonephritis
    • Bacteremia - unknown source
    • Septic pelvic thrombosis

  13. Number of Participants With Venous Thromboembolism [ Time Frame: delivery through discharge ]
    Maternal deep venous thrombosis or pulmonary embolism

  14. Number of Participants With Indications for Cesarean Delivery [ Time Frame: Labor and delivery ]
    Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication

  15. Duration of Respiratory Support [ Time Frame: delivery through hospital discharge ]
    including ventilator, CPAP, high-flow nasal cannula (HFNC)

  16. Number of Infants With Cephalohematoma [ Time Frame: delivery through hospital discharge ]
  17. Shoulder Dystocia [ Time Frame: delivery ]
  18. Number of Infants Who Had Transfusion of Blood Products or Blood [ Time Frame: delivery through hospital discharge ]
  19. Number of Infants With Hyperbilirubinemia [ Time Frame: delivery through discharge ]
    Hyperbilirubinemia requiring phototherapy or exchange transfusion

  20. Number of Infants With Neonatal Hypoglycemia [ Time Frame: delivery through discharge ]
    glucose < 35 mg/dl and requiring IV therapy

  21. Number Infants Admitted to NICU or Intermediate Care [ Time Frame: delivery through hospital discharge ]
    Number infants admitted to intensive care unit (NICU) or intermediate care unit

  22. Number of Hours on the Labor and Delivery Unit [ Time Frame: Hours from admission to L&D to discharge from L&D ]
    Median duration of stay in labor and delivery unit

  23. Maternal Postpartum Length of Hospital Stay [ Time Frame: delivery through hospital discharge ]
  24. Neonatal Length of Hospital Stay [ Time Frame: delivery through hospital discharge ]
  25. Number of Participants With Indications for Operative Vaginal Delivery [ Time Frame: Labor and delivery ]
    Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications

  26. Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery [ Time Frame: 4-8 weeks after delivery ]
    Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nulliparous - no previous pregnancy beyond 20 weeks
  2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria:

  1. Project gestational age at date of first ultrasound is > 20 weeks 6 days
  2. Plan for induction of labor prior to 40 weeks 5 days
  3. Plan for cesarean delivery or contraindication to labor
  4. Breech presentation
  5. Signs of labor (regular painful contractions with cervical change)
  6. Fetal demise or known major fetal anomaly
  7. Heparin or low-molecular weight heparin during the current pregnancy
  8. Placenta previa, accreta, vasa previa
  9. Active vaginal bleeding greater than bloody show
  10. Ruptured membranes
  11. Cerclage in current pregnancy
  12. Known oligohydramnios, defined as AFI < 5 or MVP < 2
  13. Fetal growth restriction, defined as EFW < 10th percentile
  14. Known HIV positivity because of modified delivery plan
  15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
  16. Refusal of blood products
  17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
  18. Delivery planned elsewhere at a non-Network site
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990612


Locations
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United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University
Stanford, California, United States, 94305-5317
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, Illinois
Northwestern University-Prentice Hospital
Chicago, Illinois, United States, 60611
United States, New York
Columbia University-St. Luke's Hospital
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, United States, 75235-9032
University of Texas - Galveston
Galveston, Texas, United States, 77555
University of Texas - Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Director: Menachem Miodovnik, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center
Study Chair: William Grobman, MD Northwestern University
  Study Documents (Full-Text)

Documents provided by The George Washington University Biostatistics Center:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] October 31, 2013

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT01990612    
Other Study ID Numbers: HD36801-ARRIVE
UG1HD027869 ( U.S. NIH Grant/Contract )
UG1HD027915 ( U.S. NIH Grant/Contract )
UG1HD034116 ( U.S. NIH Grant/Contract )
UG1HD034208 ( U.S. NIH Grant/Contract )
UG1HD040500 ( U.S. NIH Grant/Contract )
UG1HD040485 ( U.S. NIH Grant/Contract )
UG1HD040544 ( U.S. NIH Grant/Contract )
UG1HD053097 ( U.S. NIH Grant/Contract )
UG1HD040545 ( U.S. NIH Grant/Contract )
UG1HD040560 ( U.S. NIH Grant/Contract )
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
UG1HD040512 ( U.S. NIH Grant/Contract )
UG1HD068258 ( U.S. NIH Grant/Contract )
UG1HD068268 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
UG1HD068282 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2013    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.
Keywords provided by The George Washington University Biostatistics Center:
Induction of labor
Expectant management of labor
39 weeks gestation